Applied Clinical Trials
The need for robust and standardized psychiatric outcomes measures in oncology trials has grown immensely
The need for robust and standardized psychiatric outcomes measures in clinical trials has increased in importance over the past several years. Biopharmaceutical enterprises are paying close attention to payer scrutiny in evaluating the value of new medical products, particularly in oncology and orphan disease indications. Governmental reimbursement authorities and payers are now requiring data that not only demonstrate the scientific value of a medical product, but also show improvements in a patient's quality of life (QOL) during reimbursement review.
Companies are touching on the notion of introducing clinical interventions during clinical trials, such as palliative care methodology, in order to better demonstrate the impact of their medical products in improving patient QOL outcomes. However, significant psychological effects, such as suicide ideation, are becoming critical points of measurement in QOL outcomes, and drug manufacturers are limited to very few validated psychological assessment systems.
Many patients experience psychological problems when they have been diagnosed with cancer, and undergo oncology treatment. Patients experience significant psychological effects from facing death, financial issues, emotional ties with friends and family, and adverse medical outcomes from oncological therapy. The psychological effects are so severe that some patients consider suicide. In fact, cancer patients are twice as likely to commit suicide compared to the general population. Sponsors are increasingly using suicidal risk assessment tools in their protocols after the release of FDA's suicidal ideation and behavior guidance document, which encourages sponsors to prospectively assess suicidal ideation in clinical trials, and recommends that they use the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trial design.
While these scales obviously ask patients about killing themselves, patients may not be truthful about their feelings of suicidal ideation due to fear that they may no longer qualify for an oncology trial, according to qualitative patient feedback. With emerging data from psychiatric treatment databases, researchers are now closer toward identifying suicidal patients through a variety of factors, such as religious beliefs, drug and alcohol abuse, marital status, sleeping patterns, and much more.
We analyzed psychiatric data on more than 2,000 New York City patients from Treatment Online, a validated online psychiatric platform that engages patients and clinicians. We have discovered statistical associations, which suggest that single people are more likely to have suicidal thoughts than those who are married, the stress of a relationship breakup (or death) significantly increased suicidal plan risk, and religious people are less likely to be depressed than atheists/agnostics.
Sponsors can leverage validated and licensed psychiatric scales in order to assess the impact and progression of suicidal ideation in cancer clinical trials. Moreover, study teams can use the aforementioned data analyses to not only develop predictive and risk models on suicidal ideation, but also create analytical benchmarks to improve sensitivity analyses.
This data can also benefit palliative care in healthcare settings and clinical trials, as understanding factors that affect suicidal ideation can impact intervention in palliative care. With regulatory agencies now starting to look at patient QOL perspectives in the approval process, pairing medical products with clinical intervention and palliative care during clinical trials can enhance therapeutic benefits.
Chief Data Scientist, Annex Clinical